Last data update: May 13, 2024. (Total: 46773 publications since 2009)
Records 1-9 (of 9 Records) |
Query Trace: Melendez M[original query] |
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Accessible hepatitis C care for people who inject drugs: A randomized clinical trial
Eckhardt B , Mateu-Gelabert P , Aponte-Melendez Y , Fong C , Kapadia S , Smith M , Edlin BR , Marks KM . JAMA Intern Med 2022 182 (5) 494-502 IMPORTANCE: To achieve hepatitis C elimination, treatment programs need to engage, treat, and cure people who inject drugs. OBJECTIVE: To compare a low-threshold, nonstigmatizing hepatitis C treatment program that was colocated at a syringe service program (accessible care) with facilitated referral to local clinicians through a patient navigation program (usual care). DESIGN, SETTING, AND PARTICIPANTS: This single-site randomized clinical trial was conducted at the Lower East Side Harm Reduction Center, a syringe service program in New York, New York, and included 167 participants who were hepatitis C virus RNA-positive and had injected drugs during the prior 90 days. Participants enrolled between July 2017 and March 2020. Data were analyzed after all patients completed 1 year of follow-up (after March 2021). INTERVENTIONS: Participants were randomized 1:1 to the accessible care or usual care arm. MAIN OUTCOMES AND MEASURES: The primary end point was achieving sustained virologic response within 12 months of enrollment. RESULTS: Among the 572 participants screened, 167 (mean [SD] age, 42.0 [10.6] years; 128 (77.6%) male, 36 (21.8%) female, and 1 (0.6) transgender individuals; 8 (4.8%) Black, 97 (58.5%) Hispanic, and 53 (32.1%) White individuals) met eligibility criteria and were enrolled, with 2 excluded postrandomization (n=165). Baseline characteristics were similar between the 2 arms. In the intention-to-treat analysis, 55 of 82 participants (67.1%) in the accessible care arm and 19 of 83 participants (22.9%) in the usual care arm achieved a sustained virologic response (P<.001). Loss to follow-up (12.2% [accessible care] and 16.9% [usual care]; P=.51) was similar in the 2 arms. Of the participants who received therapy, 55 of 64 (85.9%) and 19 of 22 (86.3%) achieved a sustained virologic response in the accessible care and usual care arms, respectively (P=.96). Significantly more participants in the accessible care arm achieved all steps in the care cascade, with the greatest attrition in the usual care arm seen in referral to hepatitis C virus clinician and attending clinical visit. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, among people who inject drugs with hepatitis C infection, significantly higher rates of cure were achieved using the accessible care model that focused on low-threshold, colocated, destigmatized, and flexible hepatitis C care compared with facilitated referral. To achieve hepatitis C elimination, expansion of treatment programs that are specifically geared toward engaging people who inject drugs is paramount. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03214679. |
Accuracy of the tuberculosis point-of-care Alere determine lipoarabinomannan antigen diagnostic test using -mannosidase treated and untreated urine in a cohort of people living with HIV in Guatemala
García JI , Meléndez J , Álvarez R , Mejía-Chew C , Kelley HV , Sidiki S , Castillo A , Mazariegos C , López-Téllez C , Forno D , Ayala N , Balada-Llasat JM , Mejía-Villatoro CR , Wang SH , Torrelles JB , Ikeda J . AIDS Res Ther 2020 17 (1) 62 BACKGROUND: Improved point-of-care diagnostic tests for tuberculosis (TB) in severe immune suppressed people living with HIV (PLWH) are needed to decrease morbidity and mortality outcomes. The aim of the study is to evaluate the performance of the lipoarabinomannan antigen test (LAM-test) with and without α-mannosidase pre-treated urine in a cohort of PLWH in primary care clinics in Guatemala. We further determined TB incidence, and mortality rates and its risk factors in PLWH with TB symptoms. METHODS: Prospective longitudinal study of PLWH with TB symptoms. Urine samples were collected at 2 HIV sites to test the sensitivity of the LAM-test in urine with and without α-mannosidase pre-treatment. A composite reference standard of either a positive Mycobacterium tuberculosis complex culture and/or GeneXpert(®) MTB/RIF (Xpert, Cepheid, Sunnyvale, CA, USA) results was used in the LAM-test diagnostic accuracy studies. Cox proportional hazards regression was used to study mortality predictors. RESULTS: The overall sensitivity of the LAM-test was of 56.1% with 95% CI of (43.3-68.3). There were no differences in the LAM-test sensitivity neither by hospital nor by CD4 T cell values. LAM-test sensitivity in PLWH with < 200 CD4 T cells/µl was of 62.2% (95% CI 46.5-76.2). There were no significant differences in sensitivity when comparing LAM-test results obtained from untreated vs. α-mannosidase treated urine [55.2% (95% CI 42.6-67.4) vs. 56.9% (95% CI 44-69.2), respectively]. TB incidence in our cohort was of 21.4/100 person years (PYs) (95% CI 16.6-27.6), and mortality rate was of 11.1/100 PYs (95% CI 8.2-15.0). Importantly, PLWH with a positive LAM-test result had an adjusted hazard ratio (aHR) of death of 1.98 (1.0-3.8) with a significant p value of 0.044 when compared to PLWH with a negative LAM-test result. CONCLUSIONS: In this study, α-mannosidase treatment of urine did not significantly increase the LAM-test performance, however; this needs to be further evaluated in a large-scale study due to our study limitations. Importantly, high rates of TB incidence and mortality were found, and a positive LAM-test result predicted mortality in PLWH with TB clinical symptoms. |
Notes from the field: Obstetric tetanus in an unvaccinated woman after a home birth delivery - Kentucky, 2016
Yaffee AQ , Day DL , Bastin G , Powell M , Melendez S , Allen N , Miracle J , Jones M , Brawley R . MMWR Morb Mortal Wkly Rep 2017 66 (11) 307-308 On July 11, 2016, state and local health departments in Kentucky were notified of a case of obstetric tetanus in an unvaccinated woman. Obstetric tetanus, which occurs during pregnancy or within 6 weeks of the end of pregnancy, follows contamination of wounds with Clostridium tetani spores during pregnancy, or the use of contaminated tools or practices during nonsterile deliveries or abortions. CDC did not identify any cases of obstetric tetanus in the United States during 1972–2008 (1,2). State and local health departments in Kentucky investigated this case to identify risk factors and provide recommendations. | The patient, a woman aged 30 years, is a member of an Amish community. In late June, she delivered a child at home, assisted by an unlicensed community childbirth assistant. She had never received a vaccination for tetanus. Delivery was complicated by breech presentation, but no birth trauma, unsterile conditions, or other complications were reported. Nine days postpartum, the patient experienced facial numbness and neck pain, which progressed over 24 hours to stiff neck and jaw and difficulty swallowing and breathing. She was admitted to the hospital where a clinical diagnosis of tetanus was made, and 6,000 international units of tetanus immunoglobulin were administered intramuscularly. Endotracheal intubation and mechanical ventilation were required. Her hospital course was complicated by seizures and a need for prolonged respiratory support. After approximately a month, the patient was stable and discharged home. |
Burden of Influenza and Influenza-associated Pneumonia in the First Year of Life in a Prospective Cohort Study in Managua, Nicaragua
Gresh L , Kuan G , Sanchez N , Azziz-Baumgartner E , Ojeda S , Melendez M , Lopez R , Martin ET , Widdowson MA , Bresee J , Harris E , Balmaseda A , Gordon A . Pediatr Infect Dis J 2016 35 (2) 152-6 BACKGROUND: Influenza is a major public health problem worldwide; however, relatively little is known about influenza in tropical regions, especially for infants. Additional information is required to inform public health policy making, in particular vaccination guidelines. METHODS: Between September 2011 and July 2013, we enrolled newborns into the Nicaraguan Birth Cohort Study. Infants were provided primary medical care and actively followed for reverse-transcription polymerase chain reaction-confirmed influenza virus infection when presenting with influenza-like illness or undifferentiated fever. This report presents data pertaining to the first year of life. RESULTS: Of the 518 children enrolled in the study, 441 participated throughout their first year of life, 71 were withdrawn, and 6 died. Overall, 13% of the participants experienced at least 1 laboratory-confirmed influenza virus infection. The overall incidence of influenza was 15.5 cases per 100 person-years [95% confidence interval (CI): 12.2-19.5]. Infants aged 6-11 months experienced significantly higher rates of laboratory-confirmed influenza than infants aged 0-5 months (incidence rate ratio: 2.1; 95% CI: 1.3-3.4). The overall incidence of pneumonia was 52.6 cases per 100 person-years (95% CI: 46.3-59.6). Three percent of the pneumonia cases were influenza associated, and the incidence of influenza-associated pneumonia and hospitalization was 1.7 (95% CI: 0.9-3.5) and 0.22 (95% CI: 0.03-1.55) cases per 100 person-years, respectively. CONCLUSIONS: We found a significant burden of influenza and influenza-associated severe respiratory outcomes in infants. Our results support the need to explore the potential value of vaccinating pregnant women and infants aged >6 months, as recommended by the World Health Organization in 2012. |
Does tenofovir gel or do other microbicide products affect detection of biomarkers of semen exposure in vitro?
Snead MC , Kourtis AP , Melendez JH , Black CM , Mauck CK , Penman-Aguilar A , Chaney DM , Gallo MF , Jamieson DJ , Macaluso M , Doncel GF . Contraception 2014 90 (2) 136-41 OBJECTIVES: There is currently no information on whether products evaluated in HIV microbicide trials affect the detection of the semen biomarkers prostate-specific antigen (PSA) or Y chromosome DNA. STUDY DESIGN: We tested (in vitro) dilutions of tenofovir (TFV), UC781 and the hydroxyethylcellulose (HEC) placebo gels using the Abacus ABAcard and the quantitative (Abbott Architect total PSA) assays for PSA and Y chromosome DNA by real-time polymerase chain reaction. RESULTS: TFV gel and the HEC placebo adversely affected PSA detection using the ABAcard but not the Abbott Architect total PSA assay. UC781 adversely affected both the ABAcard and Abbott Architect total PSA assays. While there were some quantitative changes in the magnitude of the signal, none of the products affected positivity of the Y chromosome assay. CONCLUSIONS: The presence of TFV or HEC gels did not affect quantitative PSA or Y chromosome detection in vitro. Confirmation of these findings is recommended using specimens obtained following use of these gels in vivo. IMPLICATIONS: Researchers should consider the potential for specific microbicides or any products to affect the particular assay used for semen biomarker detection. The ABAcard assay for PSA detection should not be used with TFV UC781, or HEC. |
Detection of two biological markers of intercourse: prostate-specific antigen and Y-chromosomal DNA
Jamshidi R , Penman-Aguilar A , Wiener J , Gallo MF , Zenilman JM , Melendez JH , Snead M , Black CM , Jamieson DJ , Macaluso M . Contraception 2013 88 (6) 749-57 BACKGROUND: Although biological markers of women's exposure to semen from vaginal intercourse have been developed as surrogates for risk of infection or probability of pregnancy, data on their persistence time and clearance are limited. STUDY DESIGN: During 2006-2008, 52 couples were enrolled for three 14-day cycles of abstinence from vaginal sex during which women were exposed in the clinic to a specific quantity (10, 100 or 1000 muL) of their partner's semen. Vaginal swabs were collected before and at 1, 6, 12, 24, 48, 72 and 144 h after exposure for testing for prostate-specific antigen (PSA) and Y-chromosome DNA (Yc DNA). RESULTS: Immediately after exposure to 1000 muL of semen, the predicted sensitivity of being PSA positive was 0.96; this decreased to 0.65, 0.44, 0.21 and 0.07 at 6, 12, 24 and 48 h, respectively. Corresponding predicted sensitivity of being Yc DNA positive was 0.72 immediately postexposure; this increased to 0.76 at 1 h postexposure and then decreased to 0.60 (at 6 h), 0.63 (at 12 h), 0.49 (at 24 h), 0.21 (at 48 h), 0.17 (at 72 h) and 0.12 (at 144 h). CONCLUSIONS: Overall findings suggest that PSA may be more consistent as a marker of very recent exposure and that Yc DNA is more likely to be detected in the vagina after 12 h postexposure compared to PSA. |
Community diarrhea incidence before and after rotavirus vaccine introduction in Nicaragua
Becker-Dreps S , Melendez M , Liu L , Enrique Zambrana L , Paniagua M , Weber DJ , Hudgens MG , Caceres M , Kallestall C , Morgan DR , Espinoza F , Pena R . Am J Trop Med Hyg 2013 89 (2) 246-50 We estimated the incidence of watery diarrhea in the community before and after introduction of the pentavalent rotavirus vaccine in Leon, Nicaragua. A random sample of households was selected before and after rotavirus vaccine introduction. All children < 5 years of age in selected households were eligible for inclusion. Children were followed every 2 weeks for watery diarrhea episodes. The incidence rate was estimated as numbers of episodes per 100 child-years of exposure time. A mixed effects Poisson regression model was fit to compare incidence rates in the pre-vaccine and vaccine periods. The pre-vaccine cohort (N = 726) experienced 36 episodes per 100 child-years, and the vaccine cohort (N = 826) experienced 25 episodes per 100 child-years. The adjusted incidence rate ratio was 0.60 (95% confidence interval [CI] 0.40, 0.91) during the vaccine period versus the pre-vaccine period, indicating a lower incidence of watery diarrhea in the community during the vaccine period. |
Effect of topical vaginal products on the detection of prostate-specific antigen, a biomarker of semen exposure, using ABAcards
Snead MC , Kourtis AP , Black CM , Mauck CK , Brown TM , Penman-Aguilar A , Melendez JH , Gallo MF , Jamieson DJ , Macaluso M . Contraception 2012 88 (3) 382-6 BACKGROUND: Prostate-specific antigen (PSA) is a biomarker of recent semen exposure. There is currently only limited information on whether topical vaginal products affect PSA assays. We investigated this question using various dilutions of several vaginal products (lubricants and spermicides) and the Abacus ABAcard for PSA detection. STUDY DESIGN: Pooled semen controls and various dilutions of nonoxynol-9 (N9), carboxymethyl cellulose (CMC), Replens, Gynol 2, K-Y jelly, Astroglide, Surgilube, combined with pooled semen dilutions, were tested for PSA using the Abacus ABAcard. RESULTS: N9 (2% with saline) and CMC did not appear to affect the results of testing with the ABAcard, but not all semen dilutions were tested. The other products (including Replens and Gynol, which is 2% N9 with propylene glycol, K-Y, Astroglide and Surgilube) at some of the dilutions tested either affected or gave invalid results with PSA testing using the ABAcard. Both Gynol 2 and K-Y at 1:10 dilution gave false-positive results. CONCLUSIONS: Some vaginal products affect PSA results obtained by using the semiquantitative ABAcard. In vivo confirmation is necessary to further optimize PSA detection when topical vaginal products are present. |
Understanding disparities in HIV infection between black and white MSM in the United States
Oster AM , Wiegand RE , Sionean C , Miles IJ , Thomas PE , Melendez-Morales L , Le BC , Millett GA . AIDS 2011 25 (8) 1103-12 OBJECTIVE: We evaluated several hypotheses for disparities in HIV infection between black and white MSM in the United States, including incarceration, partner HIV status, circumcision, sexual networks, and duration of infectiousness. DESIGN: The 2008 National HIV Behavioral Surveillance System (NHBS), a cross-sectional survey conducted in 21 US cities. METHODS: MSM were interviewed and tested for HIV infection. For MSM not previously diagnosed with HIV infection, we used logistic regression to test associations between newly diagnosed HIV infection and incarceration history, partner HIV status, circumcision status, and sexual networks (older partners, concurrency, and partner risk behaviors). For HIV-infected MSM, we assessed factors related to duration of infectiousness. RESULTS: Among 5183 MSM not previously diagnosed with HIV infection, incarceration history, circumcision status, and sexual networks were not independently associated with HIV infection. Having HIV-infected partners [adjusted odds ratio (AOR) = 1.9, 95% confidence interval (CI) = 1.2-3.0] or partners of unknown status (AOR = 1.4, CI = 1.1-1.7) were associated with HIV infection. Of these two factors, only one was more common among black MSM - having partners of unknown HIV status. Among previously diagnosed HIV-positive MSM, black MSM were less likely to be on antiretroviral therapy (ART). CONCLUSION: Less knowledge of partner HIV status and lower ART use among black MSM may partially explain differences in HIV infection between black and white MSM. Efforts to encourage discussions about HIV status between MSM and their partners and decrease barriers to ART provision among black MSM may decrease transmission. |
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- Page last updated:May 13, 2024
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